BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇬🇧 United Kingdom

    DECAPINOL ORAL RINSE

    K Number: DEN050001 · Decision Apr 18, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    84

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    DECAPINOL ORAL RINSE
    K Number
    DEN050001
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    872.5580
    Medical Specialty
    Dental
    Decision
    Unknown
    Applicant
    Sinclair Pharmaceuticals Limited
    Date Received
    January 24, 2005
    Decision Date
    April 18, 2005
    Product Code
    NTO
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NTO Rinse, Oral, Antibacterial (By Physical Means)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NTO), ordered by most recent decision date.

    SINCLAIR ORAL RINSE

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    Other Clearances by Sinclair Pharmaceuticals Limited

    K Number Device Name
    K053166 SINCLAIR ORAL RINSE